A Prospective Randomized Clinical Trial to Study the Effect of Pre-Epidural Ultrasound Examination on Epidural Insertion Site Pressure Sensitivity in Parturient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Epidural Pressure Sensitivity at Level of Epidural Insertion
研究概览
简要总结
Historically, women who have chronic back pain after pregnancy have attributed the cause to the epidural procedure. While many studies have shown no greater incidence of generalized post-partum back pain in those who received an epidural, no studies have measured localized pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might limit patient's mobility and activities in the post-partum period. Understanding the factors that increase insertion site pressure sensitivity will allow the investigators to modify epidural placement technique in order to minimize this effect.
详细描述
Few studies have examined how epidural placement changes localized sensation at the epidural insertion site. This study will be the first study to quantitatively measure sensation at the epidural insertion site. The investigator will assess localized pressure sensitivity with an algometer. An algometer is a hand-held device commonly used by neurologist to detect sensory deficits and measures the pressure sensitivity threshold in a 1-cm diameter circular area. Ultrasound (US) pre-procedural examination provides more accurate landmarks for the placement of epidural catheters. The investigator will determine if an US examination prior to epidural placement reduces localized pressure sensitivity. The investigator will also determine if there are correlations between the participants characteristics and/or comorbidities and increased pressure sensitivity at the insertion site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant with term (37 - 41 weeks) singleton gestation
- •active labor
- •history of normal pregnancy
- •request an epidural
- •age between 18 - 35 years old
- •able to understand the protocol and provide voluntary, written, informed consent.
排除标准
- •history of spinal surgery
- •scoliosis
- •epidural or spinal placement within the last 5 days
- •neuropathic pain disorders
- •chronic opioid use
- •Texas Department of Criminal Justice patient
- •placental percreta
- •placental increta
- •placenta accreta
- •preeclampsia
- •eclampsia
研究组 & 干预措施
US-epidural SVD
US-epidural SVD group - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity
干预措施: US-epidural SVD (Procedure)
(US sham- epidural SVD)
US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.
干预措施: US sham- epidural SVD (Procedure)
SVD without an Epidural
Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline.
干预措施: Spontaneous vaginal delivery without an Epidural (Procedure)
结局指标
主要结局
Epidural Pressure Sensitivity at Level of Epidural Insertion
时间窗: Epidural pressure sensitivity was monitored 10 minutes prior to epidural insertion and then for 10 minutes on each day after epidural removal for 3 days.
pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
次要结局
- Induction Medication(The chart review will determine the use of induction medication immediately prior to the epidural placement)
- Short-term Back Pain(Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement)
- Opioid Use During Labor(A chart review of systemic opioids given to participant when the epidural is removed)
- Number of Needle Repositions(The number of needle reposition will be counted during epidural placement.)
- Number of Needle Insertions(The number of needle insertions will be counted during epidural placement.)